Observational Study to Analyse the Impact of Nurse Suppor... | NCT00787657

Studies
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment

NCT00787657

Sponsor

Bayer

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

1,723Actual

Phase

Not provided

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

Interferon beta-1b (Betaseron, BAY86-5046)

Countries

Argentina
Bahrain
Belgium
Bosnia and Herzegovina
Canada
China
Colombia
Czechia
Egypt
Estonia
France
Germany
Iran
Israel
Italy
Jordan
Kuwait
Lebanon
Libya
Mexico
Netherlands
New Zealand
Norway
Pakistan
Portugal
Saudi Arabia
Singapore
Slovakia
Slovenia
South Korea
Sweden
Syria
Taiwan
United Arab Emirates
United Kingdom
Venezuela

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
311941	Other Identifier	company internal
BF0703	Other Identifier	company internal

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Sep 2013Actual

Completion Date

Oct 2014Actual

First Submitted Date

Nov 6, 2008

First Submission Date that Met QC Criteria

Nov 6, 2008

First Posted Date

Nov 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 15, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,723Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1			Drug: Interferon beta-1b (Betaseron, BAY86-5046)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Interferon beta-1b (Betaseron, BAY86-5046)	Drug	Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients adhering to treatment		6, 12, 18 and 24 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of early treatment termination		6, 12, 18 and 24 months
Rate of study dropout		6, 12, 18 and 24 months
Predictive value of BL parameters, WCQ, HADS, RODQ

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients after first clinical event suggestive of multiple Sclerosis (MS) (according to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis.

Exclusion Criteria:

Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients after clinical events suggestive of MS according to SMPC) and patients with elapsing / Remitting Multiple Sclerosis (RRMS) within the first two years of diagnosis

Sampling Method

Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34425763	Derived	Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.

Facility	Status	City	State	ZIP	Country	Contacts
		Many Locations			Argentina

ID	Term
D009103	Multiple Sclerosis
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D016899	Interferon-beta
D007370	Interferon Type I
D007372	Interferons
D016207	Cytokines
D036341	Intercellular Signaling Peptides and Proteins
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D011506	Proteins
D001685	Biological Factors